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Ontario coverage, price, criteria word for word, Health Canada status and shortages for one product

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Listed in the December 27, 2023 extract; not in the current extract (Aug 26, 2026): PMS-Testosterone (02322498). Source: odb-formulary-ed43-extract-2023-12-27.xml; compared with odb-formulary-ed43-extract-2026-08-26.xml.

TESTOSTERONE UNDECANOATE

1 Limited Use · 1 not a benefit

Other products in the same Health Canada class (G03BA) — coverage varies; not interchangeable

  • Testosterone (Androgel): limited Use 397
  • Testosterone cypionate (Depo-Testosterone): limited Use 397, Not a benefit
  • Testosterone enanthate (Delatestryl): limited Use 397, Not a benefit

Taro-Testosterone · DIN 02421186 · 40mg · capsule

Limited Use — Reason for Use code 397 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 397 required
Write on scriptLU code 397 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 397
Reason for Use code 397 For male patients with confirmed low morning serum testosterone levels associated with documented, symptomatic hypothalamic, pituitary or testicular disease, or in HIV-infected patients. Note: Older males with nonspecific symptoms of fatigue, malaise, depression who have a low normal random testosterone level do not satisfy these criteria. Coverage limit: LU Authorization Period: 1 year
1 brand, same coverage
Taro-Testosterone · DIN 02421186 Manufacturer: Taro Pharmaceuticals Inc.; listing date 2014-10-29 Health Canada: Marketed since 2014-09-02 · brand TARO-TESTOSTERONE · ATC G03BA03 TESTOSTERONE · form Capsule · route Oral · ingredients TESTOSTERONE UNDECANOATE 40 MG · company Taro pharmaceuticals inc · schedule Controlled drugs (cdsa iv)
Check this DIN again · Health Canada product record

Taro-Testosterone: Formulary list price $0.5649/unit (unit not stated in source; not the patient's cost)

Ministry pays: $0.5649 per source unit.

Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90578 · Verify on the e-Formulary ↗ (DIN 02421186)

Source record
DIN 02421186: Taro-Testosterone Raw flags: sec12=Y, sec3=Y Item: 680800025; group id 726; item number 1789; lccId 00177; manufacturer id TAR Source form: Cap; strength: 40mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $0.5649; ministry $0.5649 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02421186 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90578
Interchangeable products
Andriol · DIN 00782327 · not recorded
Shortage status: resolved shortage (ended 2026-06-10); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02421186
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Andriol · DIN 00782327 · 40mg · capsule

Listed, not a benefit; Health Canada lists this DIN as Cancelled post market since 2018-01-29 — choose a marketed DIN from the same-category list.Discontinued 2018-01-29 · checked 2026-09-02
StatusListed, not a benefit; Health Canada lists this DIN as Cancelled post market since 2018-01-29 — choose a marketed DIN from the same-category list.
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives; Health Canada lists this DIN as Cancelled post market since 2018-01-29 — choose a marketed DIN from the same-category list.
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 397
Reason for Use code 397 For male patients with confirmed low morning serum testosterone levels associated with documented, symptomatic hypothalamic, pituitary or testicular disease, or in HIV-infected patients. Note: Older males with nonspecific symptoms of fatigue, malaise, depression who have a low normal random testosterone level do not satisfy these criteria. Coverage limit: LU Authorization Period: 1 year
1 brand, same coverage
Andriol · DIN 00782327 Manufacturer: Organon Canada Ltd./Ltee; listing date 1996-10-01 Health Canada: Cancelled post market since 2018-01-29 · brand ANDRIOL · ATC G03BA03 TESTOSTERONE · form Capsule · route Oral · ingredients TESTOSTERONE UNDECANOATE 40 MG · company Merck canada inc · schedule Controlled drugs (cdsa iv)
Check this DIN again · Health Canada product record

Andriol: Formulary list price not recorded/unit (unit not stated in source; not the patient's cost)

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=13411 · Verify on the e-Formulary ↗ (DIN 00782327)

Source record
DIN 00782327: Andriol Raw flags: notABenefit=Y, sec3=Y Item: 680800025; group id 726; item number 1789; lccId 00177; manufacturer id ORG Source form: Cap; strength: 40mg Recorded listing: Listed, not a benefit; ODB pays only for the benefit products in this interchangeable category Source prices (unrounded): not recorded; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=00782327 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=13411
Interchangeable products
Taro-Testosterone · DIN 02421186 · $0.5649
Shortage status: discontinued (2018-01-29, reported by MERCK CANADA INC); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=00782327
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Cancelled post market since 2018-01-29 — choose a marketed DIN from the same-category list.
Other drugs in the same formulary class (68:08 Androgens) and how they are covered

Matched class: 68:08 Androgens

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. Covered without a code on the Ontario formulary: DANAZOL 68:08 Androgens

TESTOSTERONE

· 5 products · Limited Use, codes 397 · strengths: 1% · 2.5g Foil Packet, 5.0g Foil Packet, Top Gel-5g Pk

TESTOSTERONE CYPIONATE

· 2 products · Listed, not a benefit (1), Limited Use, codes 397 (1) · strengths: 100mg/mL · Oily Inj Sol-10mL Pk

TESTOSTERONE ENANTHATE

· 2 products · Listed, not a benefit (1), Limited Use, codes 397 (1) · strengths: 1000mg/5mL · Oily Inj Sol-5mL Pk

DANAZOL

· 2 products · General benefit · strengths: 100mg, 200mg · Cap Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 68:08
Full class listing Related classes: 68:04 Corticosteroids, 68:12 Contraceptives, 68:16 Estrogens, 68:20 Anti-Diabetic Agents, 68:24 Parathyroid Agents, 68:28 Pituitary Agents, 68:32 Progestogens and Oral Contraceptives, 68:36 Thyroids, 68:38 Anti-Thyroids Same formulary class, not same indication: class membership alone does not establish equivalent uses.
Other drugs whose Health Canada label lists a similar indication: testosterone replacement therapy
From Health Canada product monographs; label wording only, not a treatment recommendation. Matching is lexical and uses one held product label per generic; formulations and qualifying criteria may differ. No displayed matched alternative is a general benefit. TESTOSTERONE CYPIONATE · Listed, not a benefit (1), Limited Use, codes 397 (1) INDICATIONS AND CLINICAL USE TARO–TESTOSTERONE CYPIONATE INJECTION (testosterone cypionate injection) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). PM: https://pdf.hres.ca/dpd_pm/00066102.PDF; date May 26, 2022; DIN 02496003; fetched 2026-09-10 Product monograph TESTOSTERONE ENANTHATE · Listed, not a benefit (1), Limited Use, codes 397 (1) INDICATIONS AND CLINICAL USE Testosterone Enanthate Injection, USP (testosterone enanthate) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). PM: https://pdf.hres.ca/dpd_pm/00071616.PDF; date not captured; DIN 02536315; fetched 2026-09-10 Product monograph Coverage source: ON formulary extract 2026-08-26
What the Health Canada label says it is for
INDICATIONS AND CLINICAL USE Taro-Testosterone (testosterone undecanoate capsules) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Taro-Testosterone should not be used to treat non-specific symptoms suggestive of hypogonadism if testosterone deficiency has not been demonstrated and if other etiologies responsible for the symptoms have not been excluded. Testosterone deficiency should be clearly demonstrated by clinical features and confirmed by two separate validated biochemical assays (morning testosterone) before initiating therapy with any testosterone replacement, including Taro-Testosterone treatment. Geriatrics (> 65 years of age): There is limited Taro-Testosterone use in the geriatric population. (see CLINICAL TRIALS) Pediatrics (< 18 years of age): Taro-Testosterone is not indicated for use in children < 18 years of age since safety and efficacy have not been established in this patient population (see WARNINGS AND PRECAUTIONS) Taro-Testosterone (testosterone undecanoate capsules) 40 mg Page 3 of 28 https://pdf.hres.ca/dpd_pm/00048154.PDF PM date: not printed or not captured Source product: TARO-TESTOSTERONE; DIN 02421186; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Availability

Andriol · DIN 00782327 Shortage status: discontinued (2018-01-29, reported by MERCK CANADA INC); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=00782327

Check this DIN again

Other review policies

For Andriol: no applicable EAP criteria are held and no ODB benefit is established. These policies do not establish coverage.

For rare, immediately life-, limb- or organ-threatening circumstances, the Compassionate Review Policy may consider an unfunded drug or indication, subject to its criteria and without bypassing the drug review process. Compassionate Review Policy

Compassionate Review Policy: source quote
Where there are rare clinical circumstances in immediately life, limb, or organ-threatening conditions, the Executive Officer will also consider requests for drugs or indications in situations where there has not been a decision by the Executive Officer to provide funding of the drug or indication as part of the Ontario Drug Benefit program (and the EAP), and the drug or indication requested would not circumvent the established review process for new drugs or indications as part of the drug submission process for listing within the Ontario Drug Benefit program. Requests must meet the criteria for the Compassionate Review Policy.

Ontario source; updated September 15, 2026

For cancer drugs, Case-by-Case Review considers rare, immediately life-threatening circumstances when no satisfactory funded treatment exists; its criteria and application process apply. Case-by-Case Review (cancer drugs)

Case-by-Case Review (cancer drugs): source quote
Note: Requests for cancer drugs are considered under the Case-by-Case Review Program (CBCRP) which is administered by Ontario Health (Cancer Care Ontario) on behalf of the Ministry of Health. The CBCRP considers funding requests for drugs (both oral therapies and injectable drugs) for the treatment of cancer in patients who have a rare clinical circumstance that is immediately life-threatening (death is likely within a matter of months) and who require treatment with an unfunded drug, because there is no other satisfactory and funded treatment. Please refer to the Ontario Health website for information on the application process, FAQs, eligibility criteria and program policies.

Ontario source; updated September 15, 2026